Pharmaceutical Fraud: Off-Label Marketing of Drugs in the United States, 2009-2016

Abstract

The Federal False Claims Act (FCA) is a law that enforces liability on companies (or persons) who defraud government programs. Its original purpose was to combat fraud against the United States Army during the Civil War. Under the original FCA private citizens could file a lawsuit on behalf of the government and receive a percentage of the recovery.

The False Claims Act has been somewhat effective in combating fraudulent claims by pharmaceutical manufacturers. According to the Department of Justice (DOJ) website over $19 billion has been collected from the pharmaceutical companies for various violations of the FCA including billing, marketing and pricing schemes.

Our research focused on all cases involving pharmaceutical manufacturers through False Claims Act (FCA) violations, specifically the Off-Label Marketing of Drugs. There were 22 cases in the eight years that our research covered. The total amount collected in the eight years was over $14.1 billion (Table). This was only those cases related to Off-Label Marketing. One company, Pfizer Corp., was involved in 4 of the 22 cases totaling $3,448 million over a five-year period. Johnson & Johnson Corp. settled 3 cases for a total of $2,299 million.